The Ampicillin in Infants Study

Evaluating the safety and pharmacokinetics of the commonly used antibiotic ampicillin in infants by reviewing previously collected clinical data.

The goal of this study was to evaluate the pharmacokinetics and safety of ampicillin for the treatment of sepsis and/or meningitis in infants at various gestational ages, chronological ages, and birth weights.

Summary

Ampicillin is the most commonly prescribed medication in the neonatal intensive care unit (NICU), used for treatment of bacterial infections including sepsis and meningitis. However, information was lacking on dosing and safety in the infant population.

We examined prospectively collected data from infants admitted between 1997 and 2010 at 305 intensive care nurseries managed by the Pediatrix Medical Group in the United States. A pharmacokinetic data analysis was performed, in combination with a retrospective chart review of collected information, to verify clinical data. We examined all recorded laboratory values and diagnoses associated with ampicillin use in infants with and without culture-proven infections. We also compared the odds of adverse events in infants receiving ampicillin alone or in combination with other antibiotics (e.g., cefotaxime, vancomycin, gentamicin).

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Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

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